Blood- and urinary concentrations of inhaled formoterol in asthmatic subjects and elite asthletes with asthma.

Phase 1

• Conditions: The purpose of this study i to assess the serum and urine concentrations of inhaled formoterol and evaluate the difference in three groups: healthy men, male asthmatic subjects and male elite athletes with asthma.; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2009-012039-14-DK
• Lead Sponsor: Respiratory and Allergy Research Unit

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-05-05
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 30

Inclusion Criteria

- Physician-diagnosed asthma with positive reversibility test og challenge test.
- Informed consent.
- Age between 18 - 45 years.
- Sex: male.
- Asthma classified as mild to moderate according to GINA guidelines.
- Used beta-2-agonist in minimum 12 months.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Smokers og ex-smokers with a smoking history of 10 pack years or more.
- Respiratory tract infections within the last 2 weeks prior to study day.
- Subjects with other chronic diseases than asthma and allergy.
- Allergy towards the study medicine.
- Use of beta-2-agonist 10 days prior to study day.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 1) To investigate the serum and urine concentrations of formoterol after inhalation of 18 microgram formoterol as one dose.<br><br>2) To investigate the serum and urine concentrations of inhaled formoterol and evaluate the difference between three groups: healthty men, male asthmatic subjects and male elite athletes with asthma.;Secondary Objective: ;Primary end point(s): Serum and urine concentrations of formoterol assessed by liquid-chromatography-mass-spectrometry.